WITH MODIFICATIONS ), S, PHONE NUMBERS OR OTHER FORMS, PLEASE VISIT THE IRB S WEBSITE AT:

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1 Modification Request Dominican College Institutional Review Board (IRB) IRB #: Date Received: IRB Approval Name & Signature: FOR MORE IRB INSTRUCTIONS, APPLICATIONS (including the RENEWAL FORM that should accompany this form for RENEWALS WITH MODIFICATIONS ), S, PHONE NUMBERS OR OTHER FORMS, PLEASE VISIT THE IRB S WEBSITE AT: TO SUBMIT THIS APPLICATION TO THE IRB: Complete the form below (sections 1-3 and the signature page) and submit the original signed copy and a single copy of all supporting documents and attachments (e.g., surveys, addenda, advertisements, support letters, etc). and mailing addresses are available at website above. Questions? Contact the chair listed at the IRB website (above). IRB QUESTIONS PRINCIPAL INVESTIGATOR RESPONSES Please make sure all cells contain a response (even if it is none or N/A ). Cells will expand to allow additional space for responses. Section 1 -- IDENTIFICATION AND BACKGROUND INFORMATION Principal Investigator Information 1 Researcher Name and Degree(s) 2 Indicate status Student Staff Faculty Other 3 Address 4 Dept/Division or other college affiliation 5 Mailing Address (for IRB correspondence) 6 Telephone and Numbers Telephone #: Contact Person (Person designated to serve as primary contact for all IRB communications). 7 Name and Degree(s) 8 Primary Role in the Research 9 Address 10 Telephone and Numbers Telephone #: Background Information 11 Currently Approved IRB Number & Study Title 12 Provide a brief synopsis of the objectives and procedures of the study (no more than one page). IRB Number: Study Title: Modification Request Page 1 of 6

2 Section 2 -- REQUESTED MODIFICATION Please check (double-click) the request modification below and complete the item (from 13 to 28) corresponding to the change indicated. Personnel Changes (Items 13-16) Protocol Changes (Items 17-29) complete item # indicated in brackets Change in PI [13] Change title of study [17] Revised instruments/materials [24] Change in Co-investigator [14] Additional title [18] Change in study population [25] Change in Study Contact [15] Change source of funding [19] Change in consent process/form [26] Personnel Financial Disclosure [16] Change in study length [20] Change in subject recruitment [27] Change in # of participants [21] Change in research site(s) [22] Revised procedures [23] Other: [28] [Please specify] CHANGE IN PERSONNEL Complete all items in this section (13-16) 13 Change in the Principal Investigator (PI). The PI is the primary investigator responsible for this study. Please note that this request must be accompanied by documentation that supports the new PI has completed the Ethics Tutorial (see IRB website) and received a certificate within the past 3 years. I request that the following PI(s) be DELETED from the study: I request that the following PI(s) be ADDED to the study: Please attach the revised Informed Consent / Permission / Assent document(s) to reflect this change 14 Change in a Co-Investigator. I request that the following Co-Investigator(s) be Please note that this request must be accompanied by documentation that supports the new PI has completed the Ethics Tutorial (see IRB website) and received a certificate within the past 3 years. 15 Change who is designated to receive IRB correspondence (study contact). a) Name and Degree(s) b) Primary Role in the Research c) Mailing Address (where you prefer to receive IRB correspondence) d) Address DELETED from the study: I request that the following Co-Investigator(s) be ADDED to the study: Please attach the revised Informed Consent / Permission / Assent documents, as applicable e) Telephone Number Telephone #: [Please specify] Modification Request Page 2 of 6

3 TO FIND OUT IF YOU OR ANY OTHER INVESTIGATOR INVOLVED WITH THIS PROJECT MAY HAVE A FINANCIAL CONFLICT OF INTEREST THAT NEEDS TO BE DISCLOSED, PLEASE READ OUR FULL SET OF INSTRUCTIONS AVAILABLE AT THE IRB WEBSITE. 16 Do any of the new research personnel (listed in items 13-15), or spouses or dependent children, or any of the study personnel have financial or other interests related to this project or that may be perceived to be related to this project? No. Yes. Describe the real or perceived conflict. If the conflict involves financial or other interests, complete Conflict of Financial Interest Form available at IRB website. Description of conflict: CHANGE IN PROTOCOL Complete the relevant Items below (17-27) 17 Change in the title of the study. What is the new title of the study and provide justification for this change. Please change the title to: Justification: 18 Addition of a short title (e.g., to appear on the New short title: Informed Consent). Justification: 19 Change in the sponsors or sources of funding for the study. List the current sponsors/sources of funding and provide a complete copy of the new sponsor s protocol or grant/funding proposal (with the budgetary information): 20 Change in the projected length of the study. Please indicate the new anticipated ENDING date: 21 Change in the number of participants. Please provide the new number of participants being requested and provide justification for the increase/decrease: 22 Change in research site(s). Please list the new site(s) and provide justification for the 23 If you are requesting a change in procedure(s), change in survey instruments, focus group questions, questionnaires, or test instruments. Complete this item, provide a justification and attach a copy of revised instruments, surveys, etc with the changes highlighted. If the procedures have been changed, describe how this information will be shared with both new participants (revised consent document) and currently enrolled participants (e.g., will you reconsent and when that will occur). 24 If you are requesting a change in the participant population, indicate the new population you wish to recruit and complete (a) (d). (a) What justification can you provide for addition of these sites: Please attach letters of support from each new site. Describe the changes in detail: Justification: Be sure to attach a copy of any revised instrument, questionnaire, etc. with the changes highlighted. New Population: Modification Request Page 3 of 6

4 wanting to enroll this new population? (b) Do any new safeguards need to be put in place to protect this new population? (c) Does the consent form appropriately reflect information that is relevant to the new population? (d) Does this involve a change in inclusion criteria such as age range, gender, ethnicity, race? Describe fully. 25 Change in the informed consent process or informed consent document(s). Explain the reason for the changes and attach one copy of the revised documents, with the changes highlighted in one copy. I am requesting waiver or alteration of consent documentation or waiver of the consent process. Explain: 26 Change in method of identifying potential participants or in how those potential participants will be recruited. a) Describe your recruitment procedures. b) State how you will identify potential participants and address whether this involves a potential invasion of privacy? c) Who will be involved in (have responsibility for) recruitment? 27 Describe any other requested changes which have not previously been described. Please attach any supporting documents that will assist the IRB in its review. Note: Please attach copies of any recruiting materials, e.g., flyers, brochures, advertisements. Section 3 -- MODIFICATION IMPACT Please answer EACH question below regardless of type of modification request. 28 Does this modification increase the risks to participants such that a plan to monitor the data for the safety of participants in now required? No Yes. 29 If you anticipate any changes in the risk/benefit ratio as a result of the modification(s) requested, please provide the following information (a and b) for each requested change that will affect the risk/benefit ratio. Please Note: Changes in the risk/benefit ratio related to an adverse event must be reported to the IRB using the Adverse Event Form available at the IRB web site. No Yes. Describe how this information will be provided to participants so they may consider whether they want to continue participation. a) Indicate whether you anticipate the change in the risk/benefit ratio to be minor or significant. b) Please describe the change in the risk/benefit ratio. 30 Does this modification request now require you No. to use, receive, and/or disclose protected health information (PHI) in the course of conducting Yes. Explain: this research? Modification Request Page 4 of 6

5 Modification Request Page 5 of 6

6 PRINCIPAL INVESTIGATOR S STATEMENT OF ASSURANCE I confirm the accuracy of this report. I understand that I must obtain prior approval from the IRB before amending or altering this research project or implementing changes in the approved informed consent document (submit a Modification Request form). I certify that this research study is being conducted in accordance with the terms of Ethical Principles set forth in the Belmont Report and the IRB policies of Dominican College for the protection of humans participating in research. Signature of Principal Investigator Date Signature of Co-Investigator or Faculty Advisor (if applicable) Date Modification Request Page 6 of 6